510(k) Report

FDA applicant

Hangzhou Jimushi Meditech Co., Ltd.

Hangzhou, CN3 decisions2020–20260 recalls

FDA records 3 decisions for Hangzhou Jimushi Meditech Co., Ltd. (Hangzhou, CN) from 2020 to 2026: 3 510(k) clearances. Most are in product codes EZD (Catheter, Straight) and GBM (Catheter, Urethral). Since 2016 its 510(k)s took a median of 138 days from receipt to decision, against 214 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Hangzhou Jimushi Meditech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12023: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Hangzhou Jimushi Meditech Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hangzhou Jimushi Meditech Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • EZDCatheter, Straight2decisions
  • GBMCatheter, Urethral1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 138 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 214 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 20203cite it

What has FDA decided for it lately?

  • K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd. · 2026
  • K222677Intermittent nelaton catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2023
  • K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd. · 2020

All 3 as Hangzhou Jimushi Meditech Co., Ltd. →